23 October 2020
The Food and Drug Administration (FDA) has today authorised a restart of clinical trials of the ChAdOx1 nCov-2019 Oxford coronavirus vaccine in the USA following the trials restarting in the UK, Brazil, South Africa and Japan.
On the 6th September, a standard review process triggered a voluntary pause to vaccination across all global trials to allow review of safety data by an independent committee. The FDA has now reached the same conclusion as other international regulators, who have deemed that the trials are safe to resume.
Professor Andrew Pollard, Chief investigator of the Oxford Vaccine Trial at Oxford University said: ‘We are very pleased the FDA has reached the same conclusion as the other regulators of the clinical trial sites around the world, declaring the trial safe to proceed in the USA. This will enable our partners AstraZeneca to begin trialling the vaccine in another 30,000 volunteers, taking our combined large scale, phase 3 clinical trials to 50,000 globally. We will continue to adhere to our rigorous safety processes while moving as quickly as possible so we can start protecting people around the world against this terrible virus as soon as possible.’
Globally over 20,000 individuals have been recruited into the clinical trials. It is commonplace that in large-scale trials, some participants will become unwell and every case has to be carefully evaluated to ensure careful assessment of safety. All routine follow-up appointments continued as normal during this period.
The University of Oxford has worked with partners AstraZeneca to provide information as required by international guidelines and regulators, and all trial investigators and participants will continue to be updated with the relevant information and this will be disclosed according to the clinical trial and regulatory standards.
Oxford University is committed to the safety of trial participants and the highest standards of conduct in clinical trials and will continue to monitor safety closely.
Notes to editors:
More information about the Oxford Vaccine Trial is available here:
Oxford Vaccine Hub: https://www.research.ox.ac.uk/Area/coronavirus-research/vaccine
Oxford Vaccine Clinical Trial: https://covid19vaccinetrial.co.uk/
About the Oxford Vaccine clinical trial
The purpose of this study is to test a new vaccine against COVID-19 in healthy volunteers.
This study aims to assess how well people across a broad range of ages could be protected from COVID-19 with this new vaccine called ChAdOx1 nCoV-19. It will also provide valuable information on safety aspects of the vaccine and its ability to generate good immune responses against the virus.
About the Oxford vaccine ChAdOx1 nCoV-19
ChAdOx1 nCoV-19 is made from a virus (ChAdOx1), which is a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees, that has been genetically changed so that it is impossible for it to grow in humans.
Genetic material has been added to the ChAdOx1 construct, that is used to make proteins from the COVID-19 virus (SARS-CoV-2) called Spike glycoprotein (S). This protein is usually found on the surface of SARS-CoV-2 and plays an essential role in the infection pathway of the SARS-CoV-2 virus. The SARS-CoV-2 coronavirus uses its spike protein to bind to ACE2 receptors on human cells to gain entry to the cells and cause an infection.
By vaccinating with ChAdOx1 nCoV-19, we are hoping to make the body recognise and develop an immune response to the Spike protein that will help stop the SARS-CoV-2 virus from entering human cells and therefore prevent infection.
About Oxford University
Oxford University has been placed number 1 in the Times Higher Education World University Rankings for the third year running, and at the heart of this success is our ground-breaking research and innovation. Oxford is world-famous for research excellence and home to some of the most talented people from across the globe. Our work helps the lives of millions, solving real-world problems through a huge network of partnerships and collaborations. The breadth and interdisciplinary nature of our research sparks imaginative and inventive insights and solutions. Through its research commercialisation arm, Oxford University Innovation, Oxford is the highest university patent filer in the UK and is ranked first in the UK for university spinouts, having created more than 170 new companies since 1988. Over a third of these companies have been created in the past three years.